510(k) K942189 ยท ESD Hearing Aid, Air-Conduction, Prescription
CRYSTAL EAR
| Applicant | Crystal Care Intl., Inc., Lutz FL, US |
| Decision | Substantially Equivalent, Aug 9, 1994 |
| Received | May 4, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K942189
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.